# K113521: Calcium Gen. 2

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: May 8, 2012 after 161 days
- Product code: CHW (Titrimetric With Edta And Indicator, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921661 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921661: Boehringer Mannheim/ Hitachi 911 Analyzer, Boehringer Mannheim Corp. (1992) Summary page 2.

## Indications for use
The Calcium Gen.2 assay is an in vitro diagnostics reagent system intended for the quantitative determination of calcium in human serum, plasma, and urine on Roche/Hitachi cobas c systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.

Source page: https://510kreport.com/device/K113521
Methodology: https://510kreport.com/methodology